The Effect of AR in Patient Pre-operative Education

The Effect of Augmented Reality in Patient Pre-operative Education

The purpose of this clinical trial is to analyze the effect of augmented reality (AR) on patient education and overall satisfaction when used during preoperative counseling in older adults undergoing spinal surgery. The main aims of this study are:

Aim 1: To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction, higher levels of confidence in surgeons, lower levels of preoperative anxiety, and lower patient reported pain scores.

Aim 2: To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals.

This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices.

Study Overview

• Status: Not yet recruiting
• Conditions: Transforaminal Lumbar Interbody Fusion; Anterior Cervical Discectomy and Fusion
• Intervention / Treatment: Other: Standard preoperative counseling; Other: Augmented Reality Enhanced Preoperative Counseling

Detailed Description

This study will be performed on elderly patients scheduled to undergo elective spinal surgery. The study will be a non-blinded, randomized clinical trial with a treatment arm and a control arm. After patient screening to determine eligibility and after patients are informed about the study and potential risks, all patients giving written informed consent will be randomized in a non-blinded manner in a 1:1 ratio to traditional preoperative patient counseling (control arm) or AR enhanced preoperative patient counseling (treatment arm). In the traditional preoperative patient counseling group, surgeons will explain the patients pathology and the surgery with only words and with or without pictures (MRI, CT, etc) and/or a generic 3D model. In the AR enhanced preoperative patient counseling group, the surgeon will have virtual, interactive models of the patients own anatomy projected through AR to show patients while describing the problem and how the surgery will be performed.

For all patients included within the treatment arm, the Medivis Surgical AR and AnatomyX platform will be deployed on the Microsoft Hololens 2 for AR image projection. When using Surgical AR, patient MRI and CT data will be accessed through the University of Pittsburgh Medical Centers Picture Archiving and Communication System (PACS) on the Medivis workstation. During preoperative consultation, the workstation will rapidly access the PACS system to pull the patients imaging and stream it to the Microsoft Hololens 2 AR-headset. For AnatomyX, a generic anatomic model is populated that can clearly present the anatomy involved in a procedure and also allows for a shared interactive space in which the patient, patient family, and surgeon can exist.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward Andrews, MD; Phone Number: ‭215-901-0687‬; Email: andrewse2@upmc.edu
• Study Contact Backup: Name: Michael R Kann, BE; Phone Number: 412-439-3794; Email: mrk176@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
      • Contact: Edward Andrews, MD; Phone Number: 412-232-5666; Email: andrewse2@upmc.edu
      • Principal Investigator: Edward Andrews, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 65 or greater years-of-age
• Undergoing elective anterior cervical discectomy and fusion (ACDF) or transforaminal lumbar interbody fusion (TLIF) spine surgery

Exclusion Criteria:

• Prior surgery
• Vestibular dysfunction
• Cannot tolerate AR immersion secondary to physical or psychiatric impairments
• Cognitive impairment
• Emergency procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Patient Pre-operative Counseling; These patients will undergo standard preoperative counseling. A standardized checklist will designate the mandatory information patients must receive during counseling including a description of the normal elements of the anatomy and abnormal elements of the anatomy relevant to each patient, a description of the basic steps of the surgical procedure and how it addresses each patient's individual problem, and a description of the potential risks, complications, and benefits of the procedure. Surgeons may augment the verbal descriptions of the preoperative counseling procedure with patient 2D MRI or CT imaging or generic 3D models or drawings. However, customized patient specific 3D printed models are not allowed.	Other: Standard preoperative counseling; Control patients will undergo standard preoperative counseling.
Experimental: Augmented Reality Enhanced Patient Pre-operative Counseling; This group of patients will undergo AR enhanced preoperative counseling. Surgeons will be provided with the same checklist of mandatory minimum information patients must receive during counseling as the control group. Both the patient and physician will wear an AR-headset. Medivis AnatomyX, a generic holographic anatomy visualization available on all AR-headset devices, will first be used to introduce the patient to normal anatomy and describe the steps of the procedure. Using Surgical AR, the patients specific imaging will then be accessed through the Medivis mobile workstation and projected into a 3D interactive model. The surgeon will use this model to highlight the patients pathology, explain how it is causing their symptoms, and review possible complications. The surgeon may refer back to the generic model in AnatomyX at any point during counseling.	Other: Augmented Reality Enhanced Preoperative Counseling; For patients undergoing AR enhanced preoperative counseling, headset-based AR holograms of standardized patient anatomy through AnatomyX as well as patient specific anatomy through SurgicalAR will be projected to assist the surgeon in educating the patient throughout preoperative counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey	The APAIS is a a preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia.	The APAIS is to be completed preoperatively on the day of the surgery
Simulator Sickness Questionnaire (SSQ)	The SSQ is used to quantify simulator sickness within individuals during or following the use of extended reality environments across 3 domains. The total score ranges from 0-235.62 with higher scores representing higher sickness.	The SSQ will be completed within 24 hours after preoperative counseling in patients undergoing AR enhanced patient pre-operative counseling
Evaluation of the Experience of General Anesthesia (EVAN-G) Survey	The EVAN-G is a patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction.	The EVAN-G will be completed within 24 hours after surgery
Time of preoperatively patient counseling	The total time it takes for a surgeon to perform preoperative patient counseling will be recorded.	Assessed during preoperative patient counseling session
Degree of knowledge acquisition questionnaire at baseline	Degree of knowledge acquisition will be determined by a post-counseling questionnaire asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The questionnaire will be quantified by a patient and physician assessment of knowledge on a 1-5 Likert scale with 1 being low knowledge acquisition and 5 being high knowledge acquisition	Knowledge acquisition will be completed within 24 hours after preoperative counseling
Degree of knowledge acquisition questionnaire 2 weeks post-operative	Degree of knowledge acquisition will be determined by a post-counseling questionnaire asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The questionnaire will be quantified by a patient and physician assessment of knowledge on a 1-5 Likert scale with 1 being low knowledge acquisition and 5 being high knowledge acquisition	Knowledge acquisition will be completed approximately 2 weeks post-operatively
Degree of knowledge acquisition questionnaire 3 months post-operative	Degree of knowledge acquisition will be determined by a post-counseling questionnaire asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The questionnaire will be quantified by a patient and physician assessment of knowledge on a 1-5 Likert scale with 1 being low knowledge acquisition and 5 being high knowledge acquisition	Knowledge acquisition will be completed approximately 3 months post-operatively
Degree of knowledge acquisition questionnaire 6 months post-operative	Degree of knowledge acquisition will be determined by a post-counseling questionnaire asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The questionnaire will be quantified by a patient and physician assessment of knowledge on a 1-5 Likert scale with 1 being low knowledge acquisition and 5 being high knowledge acquisition	Knowledge acquisition will be completed approximately 6 months post-operatively
Participant age	The patients age at the time of the intervention will be recorded	This will be documented within 24 hours after enrollment
Participant gender	The patients gender will be recorded	This will be completed within 24 hours after enrollment
Participant's indication for surgery	The patients primary diagnosis that is the reason for surgery will be recorded	This will be completed within 24 hours after enrollment
Participant education	The patients number of years of formal education will be recorded	This will be completed within 24 hours after enrollment
Participant's past surgeries	A list of the surgeries the patient has had in the past will be recorded	This will be completed within 24 hours after enrollment
Names of pain medications	The name of each pain medication a patient is taking at the time of the intervention will be recorded	This will be completed within 24 hours after enrollment
Doses of pain medications	The dose of each pain medication a patient is taking at the time of the intervention will be recorded	This will be completed within 24 hours after enrollment
Prior experience with simulated environments	This will be assessed using a Likert 1-5 scale with 1 being no experience with extended reality environments and 5 being very experienced with extended reality environments	This will be completed prior to preoperative patient counseling within those individuals assigned to the AR enhanced preoperative counseling treatment arm
Patient understanding of surgery at baseline	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear	Patient understanding will be assessed preoperatively on the the day of surgery
Patient understanding of surgery 2 weeks post-operative	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear	Patient understanding will be assessed approximately 2 weeks post-operatively
Patient understanding of surgery 3 months post-operative	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear	Patient understanding will be assessed approximately 3 months post-operatively
Patient understanding of surgery 6 months post-operative	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear	Patient understanding will be assessed approximately 6 months post-operatively
Patient pain level at baseline	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.	Pain level will be assessed preoperatively on the the day of surgery
Patient pain level 2 weeks post-operatively	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.	Pain level will be assessed approximately 2 weeks post-operatively
Patient pain level 3 months post-operatively	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.	Pain level will be assessed approximately 3 months post-operatively
Patient pain level 6 months post-operatively	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.	Pain level will be assessed around 6 months post-operatively
Confidence in surgeon at baseline	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence	Confidence in surgeon will be assessed preoperatively on the the day of surgery
Confidence in surgeon 2 weeks post-operatively	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence	Confidence in surgeon will be assessed approximately 2 weeks post-operatively
Confidence in surgeon 3 months post-operatively	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence	Confidence in surgeon will be assessed approximately 3 months post-operatively
Confidence in surgeon 6 months post-operatively	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence	Confidence in surgeon will be assessed approximately 6 months post-operatively
Patient preoperative visit satisfaction level	A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied	Patient preoperative visit satisfaction will be assessed preoperatively on the the day of surgery
Patient satisfaction level with the surgical explanation at baseline	A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied	Patient satisfaction with the surgical explanation will be assessed preoperatively on the the day of surgery
Patient postoperative visit satisfaction level 2 weeks post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied	Patient postoperative visit satisfaction will be assessed approximately 2 weeks post-operatively
Patient surgery satisfaction level 2 weeks post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied	Patient surgery satisfaction will be assessed approximately 2 weeks post-operatively
Patient postoperative visit satisfaction level 3 months post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied	Patient postoperative visit satisfaction will be assessed approximately 3 months post-operatively
Patient surgery visit satisfaction level 3 months post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied	Patient surgery satisfaction will be assessed approximately 3 months post-operatively
Patient postoperative visit satisfaction level 6 months post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied	Patient postoperative visit satisfaction will be assessed approximately 6 months post-operatively
Patient surgery satisfaction level 6 months post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied	Patient surgery satisfaction will be assessed approximately 6 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient referral rates	Patient referral rates will be tracked for 6 months following surgical intervention	Patient referral rates will be assessed up to 6 months post-operatively
Patient retention rates	Patient retention rates will be tracked for 6 months following surgical intervention	Patient retention rates will be assessed up to 6 months post-operatively
Patient preference on the type of pre-operative counseling received for the AR-specific participants	Within the AR enhanced preoperative counseling treatment group, an additional preoperative variable collected will be if the patient found generic anatomy through AnatomyX, their own anatomy through SurgicalAR, or both the best method for AR counseling	This will be assessed at the start of the study only

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Edward Andrews, MD, University of Pittsburgh Medical Center

Publications and helpful links

General Publications

• Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
• Zhuang YD, Zhou MC, Liu SC, Wu JF, Wang R, Chen CM. Effectiveness of personalized 3D printed models for patient education in degenerative lumbar disease. Patient Educ Couns. 2019 Oct;102(10):1875-1881. doi: 10.1016/j.pec.2019.05.006. Epub 2019 May 8.
• Sezer S, Piai V, Kessels RPC, Ter Laan M. Information Recall in Pre-Operative Consultation for Glioma Surgery Using Actual Size Three-Dimensional Models. J Clin Med. 2020 Nov 13;9(11):3660. doi: 10.3390/jcm9113660.
• Collins MK, Ding VY, Ball RL, Dolce DL, Henderson JM, Halpern CH. Novel application of virtual reality in patient engagement for deep brain stimulation: A pilot study. Brain Stimul. 2018 Jul-Aug;11(4):935-937. doi: 10.1016/j.brs.2018.03.012. Epub 2018 Mar 15. No abstract available.
• Eastwood D, Manson N, Bigney E, Darling M, Richardson E, Paixao R, Underwood T, Ellis K, Abraham E. Improving postoperative patient reported benefits and satisfaction following spinal fusion with a single preoperative education session. Spine J. 2019 May;19(5):840-845. doi: 10.1016/j.spinee.2018.11.010. Epub 2018 Nov 22.
• Panesar SS, Magnetta M, Mukherjee D, Abhinav K, Branstetter BF, Gardner PA, Iv M, Fernandez-Miranda JC. Patient-specific 3-dimensionally printed models for neurosurgical planning and education. Neurosurg Focus. 2019 Dec 1;47(6):E12. doi: 10.3171/2019.9.FOCUS19511.
• Rampersaud YR, Canizares M, Perruccio AV, Abraham E, Bailey CS, Christie SD, Evaniew N, Finkelstein JA, Glennie RA, Johnson MG, Nataraj A, Paquet J, Phan P, Weber MH, Thomas K, Manson N, Hall H, Fisher CG. Fulfillment of Patient Expectations After Spine Surgery is Critical to Patient Satisfaction: A Cohort Study of Spine Surgery Patients. Neurosurgery. 2022 Jul 1;91(1):173-181. doi: 10.1227/neu.0000000000001981. Epub 2022 Apr 22.
• Delgado CA, McCullers MR, Bloom SW. Evaluating the Efficacy of Surgical Consent. Am Surg. 2023 Aug;89(8):3433-3437. doi: 10.1177/00031348231161702. Epub 2023 Mar 15.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Patient Education; Augmented Reality; Preoperative Counseling
• Other Study ID Numbers: STUDY24010034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No